..Cardiovascular drugs approved in Europe in the last few years have contributed little to progress in this area. These approvals provide no real advantage to patients and lay an economic burden on society...

Efficacy, safety and cost of new drugs acting on the central nervous system

..The aim of the present work is to evaluate the efficacy and safety data used by the European Medicines Agency (EMEA) between 1995 and June 2006 to approve new immunosuppressive drugs with indications in solid organ transplantation...

New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval

..The methodological and ethical value of equivalence and non-inferiority trials is questioned. These studies are still increasingly used in drug evaluation and accepted by the scientific community and the regulatory authorities...

..This brief discussion reviews these questions and gives some examples by comparing diuretics and new antihypertensive agents, ticlopidine and clopidogrel, and atypical and classical antipsychotic agents...

Smoking in Italy 2005-2006: effects of a comprehensive National Tobacco Regulation

..On 10 January 2005 Italy became the first large European country adopting a comprehensive smoke-free legislation. We provide information on smoking prevalence in Italy and evaluate the effects of the 2005 regulations...

Fish oil and mental health: the role of n-3 long-chain polyunsaturated fatty acids in cognitive development and neurological disorders